Continuing cetuximab in combination with chemotherapy after first progression may be efficacious in selected patients with metastatic colorectal cancer (mCRC), a study published in the journal Annals of Oncology has shown.1

Cetuximab plus chemotherapy is a first-line treatment modality in patients with metastatic KRAS and NRAS wild type CRC; however, there are currently no data on the effect of continuing anti-epidermal growth factor receptor (EGFR) therapy beyond progression.

For the multicenter, open-label, phase 2 trial, researchers in Italy sought to evaluate the efficacy of cetuximab plus 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) as second-line treatment for patients with KRAS exon 2 wild type mCRC who were treated with first-line 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) plus cetuximab.

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Researchers enrolled 153 patients and randomly assigned 75 to receive FOLFOX plus cetuximab and 79 to FOLFOX alone.

Results showed that median progression-free survival was 6.4 months (95% CI, 4.7 – 8.0) with cetuximab compared with 4.5 months (95% CI, 3.3 – 5.7) with FOLFOX alone (HR, 0.81; 95% CI, 0.58 – 1.12; P = .19).

Researchers found that progression-free survival was longer in the FOLFOX plus cetuximab arm among patients with KRAS, NRAS, BRAF, and PIK3CA wild type tumors. Median progression-free survival was 6.9 months (95% CI, 5.5 – 8.2) with FOLFOX plus cetuximab vs 5.3 months (95% CI, 3.7 – 6.9) with FOLFOX (HR, 0.56; 95% CI, 0.33 – 0.94; P = .025). Researchers also observed a trend in prolonged overall survival with immunotherapy (HR, 0.57; 95% CI, 0.32 – 1.02; P = .056).

RELATED: Selective Internal Radiation Therapy Plus FOLFOX Improves Control of Liver Tumors in Colorectal Cancer

The findings suggest that continuing cetuximab and chemotherapy in molecularly selected patients following first progression should be confirmed in phase 3 studies.


  1. Ciardiello F, Normanno N, Martinelli E, et al. Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): a randomized phase 2 trial of FOLFOX plus cetuximab versus FOLFOX [published online ahead of print March 21, 2016]. Ann Oncol. doi: 10.1093/annonc/mdw136.